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RECRUITING
NCT07555548

UK PureWick™ At-Home Pilot Study

Sponsor: Becton, Dickinson and Company

View on ClinicalTrials.gov

Summary

The UK PureWick™ At-Home Study is being carried out to see how well the PureWick™ Collection System works for women who use it at home instead of a traditional catheter. Traditional catheters are placed inside the body. The PureWick™ Collection System is different, it's placed outside the body . In this study, researchers want to find out: how effective the PureWick™ Collection System is in helping women manage urine collection at home, whether patients prefer using PureWick™ Collection System over the usual catheter, how it affects their sleep, and overall well-being.The PureWick™ Collection System is intended for the treatment of patients who leak urine (called urine incontinence). The PureWick™ Collection System is designed to help manage urine in female patients without needing to insert a urinary catheter into the body.

Official title: An Open-label Pilot Study Conducted in the UK to Evaluate the Clinical Benefits of the PureWick™ Female External Catheter System Compared to Indwelling Urinary Catheters in Female Patients Receiving Home-based Care

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

95

Start Date

2026-05-06

Completion Date

2027-01

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

PROCEDURE

Treatment with the PureWick™ Urine Collection System External Catheter which is a non-invasive device designed to manage urinary incontinence

After enrollment in the study, the preceding 4 weeks will be retrospectively assessed for subjects who encountered "problematic catheters" necessitating a minimum of five interventions within the past month, involving medical treatment and HCP consultation. Following a one-week familiarization period, a four-week prospective phase will commence during which subjects will utilize the PureWick™ Female External Catheter System.

Locations (4)

Rotherham Doncaster and South Humber NHS Foundation Trust

Doncaster, United Kingdom

South Leicestershire Medical Group

Leicester, United Kingdom

NCAS- Northamptonshire Continence Advisory Service

Northampton, United Kingdom

East of England Community Health and Care NHS Trust

Norwich, United Kingdom